BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 16040532 · Received December 22, 2022

    Report

    Report Number
    1911916-2022-00773
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    December 6, 2022
    Report Date
    January 6, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 29-DEC-2022 H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS A LOOSE PARTICLE IN THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A PLASTIC BAG AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS. THERE WAS NO FOREIGN MATTER LOCATED IN THE SYRINGE OR THE PLASTIC BAG. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS A SYRINGE WITH A PIECE OF FOREIGN MATTER LOCATED AT THE 20ML MARK. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031, LOT NUMBER 2020146. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT A PROBABLE ROOT CAUSE COULD NOT BE OFFERED AS SYRINGES ARE PRODUCED IN A CONTROLLED ENVIRONMENT AND NO FOREIGN MATTER WAS RECEIVED FOR ANALYSIS OR IDENTIFICATION. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE HAD A LOOSE (CARDBOARD/PAPER) PARTICLE IN THE PISTON OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A COMPLAINT FROM A CUSTOMER ABOUT A LOOSE (CARDBOARD/PAPER) PARTICLE IN THE PISTON OF THE SYRINGE. THE PARTICLE WAS DISCOVERED BEFORE THE SYRINGE WAS FILLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE HAD A LOOSE (CARDBOARD/PAPER) PARTICLE IN THE PISTON OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A COMPLAINT FROM A CUSTOMER ABOUT A LOOSE (CARDBOARD/PAPER) PARTICLE IN THE PISTON OF THE SYRINGE. THE PARTICLE WAS DISCOVERED BEFORE THE SYRINGE WAS FILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138902 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2020146

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown